DILICIN
Research type
Research Study
Full title
Drug induced Liver Injury Cohort in Nottingham (DILICIN)
IRAS ID
142213
Contact name
Guruprasad Aithal
Contact email
Sponsor organisation
Research & Innovation
Research summary
As part of the European Union’s Innovative Medicines Initiative (IMI), a consortium called SAFE-T (Safer And Faster Evidence-based Translation) has been established in 2009 to address the urgent need for more predictive and more robust safety biomarkers for drug-induced liver injury (DILI). Many drugs can unexpectedly induce injury to the human liver; these can be life-threatening and hence, may lead to withdrawal of the drug treatment. The consortium’s aim is to qualify promising biomarkers to detect and monitor DILI in humans using peripheral samples such as blood and urine. In the context of SAFE-T’s DILI program, the aim of DILICIN study is to collect blood samples from patients with acute DILI to be used within the larger European program. The primary objective of this study is to validate genetic, epigenetic, demographic and other biomarkers that are associated with the development of DILI, its severity and the course of DILI over a 12 week period. Patients with suspected DILI will be enrolled within 3 weeks of the onset of DILI. Blood and urine samples will be taken at the entry to the study (baseline), 1 and 8 weeks later. These samples will be used for the discovery of novel biomarkers of DILI.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
13/EM/0422
Date of REC Opinion
6 Dec 2013
REC opinion
Further Information Favourable Opinion